An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1)
This research study, called NAVAL-1, is investigating a new treatment approach for certain types of lymphoma. These are lymphomas linked to the Epstein-Barr Virus (EBV) that have either come back after treatment or haven't responded to previous therapies. The study is testing a drug called nanatinostat alongside a common antiviral medicine called valganciclovir. Researchers want to see how effective this combination is at reducing the size of the cancer. This is a "Phase 2" study, meaning it's exploring how well the treatment works and is looking for promising results to help patients with these specific types of lymphoma.
At a glance
What is this study about?
This study is for people who have a specific type of cancer called lymphoma. To be part of this study, your lymphoma must be connected to a common virus called the Epstein-Barr Virus (EBV). This virus can sometimes play a role in developing certain lymphomas. The study is specifically for those whose lymphoma has either returned after being treated before (we call this 'relapsed') or hasn't improved with previous treatments (we call this 'refractory').
The main goal of this research is to test a new combination of medicines: nanatinostat and valganciclovir. Nanatinostat is a new type of drug being explored for cancer treatment, and valganciclovir is an existing medicine often used to treat viral infections. Researchers want to find out how well this combination works together to shrink the lymphoma tumours. They will be carefully checking to see how many patients experience their cancer getting smaller or disappearing after treatment.
This is a Phase 2 study, which means it's an important step in understanding how effective and safe new treatments are. If the results are promising, it could lead to better treatment options for people with EBV-positive relapsed or refractory lymphoma in the future. The information gathered will help doctors understand more about how these drugs work and whether they could become a standard treatment.
Key takeaways
- This study is for adults with a specific type of lymphoma linked to the Epstein-Barr virus.
- It's for those whose lymphoma has returned or hasn't responded to previous treatments.
- The study explores a new combination of drugs: nanatinostat and valganciclovir.
- The main aim is to see how effectively this combination shrinks the cancer.
- Participation involves regular check-ups, tests, and careful monitoring.
Who may be eligible?
To be able to join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Your specific type of lymphoma must be linked to the Epstein-Barr Virus (EBV). This means doctors will have checked for the presence of the virus in your cancer cells.
Crucially, your lymphoma must have either come back after you've had treatment for it before, or it hasn't responded to the treatments you've received. This study is designed for people who still need treatment options for their lymphoma.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Has your doctor told you that your lymphoma is linked to the Epstein-Barr Virus (EBV)?
- Has your lymphoma come back after previous treatment, or did it not respond to past treatments?
- Are you able to attend regular hospital visits for treatment and check-ups?
- Are you willing to take new medication as part of a study?
What does participation involve?
Taking part in this study means you would receive the new drug, nanatinostat, alongside valganciclovir. You would have regular appointments for check-ups, which include blood tests and scans, to see how you are responding to the treatment. These assessments will help the doctors understand if the treatment is working and how you are feeling.
The research team will closely monitor your health throughout the study. You will also have follow-up visits even after you finish the main treatment, to keep track of your long-term health and the effects of the treatment. The total duration of your participation will depend on how you respond to the treatment and the study's follow-up plan, but the main treatment phase will involve regular visits.
Potential risks and benefits
Locations (4)
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedFrance
Common questions
What is Epstein-Barr Virus (EBV)?
EBV is a very common virus, and most people get it at some point in their lives. In some rare cases, it can be linked to certain types of cancer, including some lymphomas.
What does 'relapsed' or 'refractory' mean for my lymphoma?
'Relapsed' means your lymphoma has come back after treatment. 'Refractory' means your lymphoma didn't get better or continued to grow despite previous treatments.
What is a 'Phase 2' trial?
A Phase 2 trial is a stage of research where doctors are trying to find out how well a new treatment works for a specific condition and to understand its safety in a larger group of patients.
Will I know if the treatment is working?
Yes, you will have regular tests, like scans, to monitor your lymphoma, and the study doctors will discuss your progress and any changes with you.
What is valganciclovir?
Valganciclovir is a medicine that is already used to treat certain viral infections. In this study, it's being tested alongside nanatinostat.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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